Opioid-use Disorder
Conditions
Brief summary
The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned. This multicentre investigation will enroll participants from Study RB-US-13-0003 (NCT02510014) or both Studies RB-US-13-0003 and INDV-6000-301 (NCT02896296) and who received at least 2 subcutaneous (SC) injections of SUBLOCADE. There are two parts to the study: Part A consists of a single visit during which urine samples are collected to measure free buprenorphine and free norbuprenorphine concentrations; qualitative urine drug samples (UDS) for opioids, including buprenorphine; quantitative UDS for buprenorphine, norbuprenorphine and naloxone; and determination of creatinine concentration. Blood samples are collected for the determination of buprenorphine and norbuprenorphine plasma concentrations. Results on the quantitative UDS performed in Part A determine enrollment in Part B: participants who provide a quantifiable (i.e., positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e., negative) result for naloxone meet continuation criteria to move on to Part B if Part B is still open to enrolment. Part B consists of two visits 30 days apart in which the same tests are run as were done in Part A.
Detailed description
Data indicate that after discontinuing SUBLOCADE patients may have detectable concentrations of buprenorphine in plasma and urine for 12 months or longer. Previous Phase II/III studies did not evaluate the pharmacokinetics (PK) of buprenorphine beyond 2 months after the last injection; this study will characterize the long-term plasma exposure starting at least 12 months after the last injection. The study will also assess relationships between plasma drug concentrations, free drug concentrations in urine and urine drug screen (UDS) results in order to provide refined guidance to patients and physicians with respect to long-term exposure to buprenorphine after stopping SUBLOCADE treatment.
Interventions
DIAGNOSTIC_TESTBlood sample collection
Determination of buprenorphine and norbuprenorphine plasma concentrations
DIAGNOSTIC_TESTUrine sample collection
Urine sample for determination of free buprenorphine and free norbuprenorphine concentrations, qualitative UDS for opioids, quantitative UDS for buprenorphine, norbuprenorphine and naloxone, and determination of creatinine concentration
Sponsors
Indivior Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participated in Study RB-US-13-0003 or both Studies RB-US-13-0003 and INDV-6000-301 and received at least 2 subcutaneous (SC) injections of SUBLOCADE * Within 12 to 36 months post his or her last SUBLOCADE injection at the time of the Screening Visit * Female individuals of childbearing potential must agree to have a pregnancy test administered prior to enrollment and throughout the study. Pregnancy does not prohibit participation * Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures.
Exclusion criteria
* Received SUBLOCADE or any other long-acting buprenorphine product at any time after ending their participation in Study RB-US-13-0003 or Study INDV-6000-301 * Taken any buprenorphine (prescribed or illicit) within 3 weeks prior to the Screening visit (study Part A, Visit 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Days 1, 30, 60 | The qualitative UDS (immunoassay) is the primary test used for the initial screening for opioids in patients in clinical practice. It provides only a qualitative assessment of buprenorphine exposure (i.e., positive or negative) with a low limit of quantification (LLOQ) of 5 ng/mL. The qualitative UDS is reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies. |
| Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Days 1, 30, 60 | The quantitative UDS measures both buprenorphine and its glucuronide, or both norbuprenorphine and its glucuronide, with an LLOQ of 2 ng/mL. It is typically used by physicians for the confirmation of a positive result on the qualitative UDS. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is Not Available Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies. |
| Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Days 1, 30, 60 | The urine free drug test only measures the free buprenorphine and free norbuprenorphine (without their glucuronides) with an LLOQ of 0.02 ng/mL. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is Not Available Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies. |
| Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Days 1, 30, 60 | A sensitive liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was used to assess the plasma exposure to buprenorphine and norbuprenorphine, its major metabolite. The LLOQ was 0.02 ng/mL for both analytes, which is much lower than the LLOQ of plasma/serum assays conducted by diagnostic laboratories. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is Not Available Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies. |
Countries
United States
Participant flow
Recruitment details
All investigators sites were in the U.S.
Pre-assignment details
54 subjects were screened. One did not meet eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants who enrolled into the Part A Cohort. These participants previously participated in study RB-US-13-0003 or both studies RB-US-13-0003 and INDV-6000-301 and who received at least 2 doses of SUBLOCADE 12-36 months prior. Some of the participants continued into study Part B after completing Part A. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Part A | Lost to Follow-up | 1 |
| Part A | Protocol Violation | 1 |
| Part B | Protocol Violation | 1 |
| Part B | Study terminated by sponsor | 3 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 43.0 years STANDARD_DEVIATION 11.46 |
| Age, Customized 18 - 44 years | 32 Participants |
| Age, Customized 45 - 64 years | 19 Participants |
| Age, Customized .>= 65 years | 2 Participants |
| Body Mass Index | 26.5 kg/m^2 STANDARD_DEVIATION 5.58 |
| Body Mass Index Group >= 18.5 and < 25 kg/m^2 | 24 Participants |
| Body Mass Index Group < 18.5 kg/m^2 | 1 Participants |
| Body Mass Index Group >= 25 and < 30 kg/m^2 | 15 Participants |
| Body Mass Index Group >= 30 kg/m^2 | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants |
| Race/Ethnicity, Customized White | 37 Participants |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 32 Participants |
| Weight | 79.7 kg STANDARD_DEVIATION 18.51 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B
A sensitive liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was used to assess the plasma exposure to buprenorphine and norbuprenorphine, its major metabolite. The LLOQ was 0.02 ng/mL for both analytes, which is much lower than the LLOQ of plasma/serum assays conducted by diagnostic laboratories. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is Not Available Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Time frame: Days 1, 30, 60
Population: Full analysis set includes participants who have at least one measure of buprenorphine or norbuprenorphine concentration in plasma or in urine in Part A. Four participants who tested positive for naloxone in urine were excluded from summary results. One participant was terminated from the study prior to Part B, Visit 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 15 Participants |
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 32 Participants |
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 2 Participants |
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 15 Participants |
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 32 Participants |
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 20 Participants |
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 2 Participants |
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 27 Participants |
| Part A Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 2 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 20 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 1 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 11 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 1 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 3 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 1 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 20 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 3 Participants |
| Part B Cohort: Visit 1 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 12 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 11 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 4 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 4 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 1 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 1 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 18 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 11 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 1 Participants |
| Part B Cohort: Visit 2 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 18 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 16 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 1 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 16 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 3 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 11 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 3 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 8 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 1 Participants |
| Part B Cohort: Visit 3 | Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 1 Participants |
Primary
Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B
The qualitative UDS (immunoassay) is the primary test used for the initial screening for opioids in patients in clinical practice. It provides only a qualitative assessment of buprenorphine exposure (i.e., positive or negative) with a low limit of quantification (LLOQ) of 5 ng/mL. The qualitative UDS is reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Time frame: Days 1, 30, 60
Population: Full analysis set includes participants who have at least one measure of buprenorphine or norbuprenorphine concentration in plasma or in urine in Part A. Four participants who tested positive for naloxone in urine were excluded from summary results. One participant was terminated from the study prior to Part B, Visit 2.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort: Visit 1 | Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Positive | 27 Participants |
| Part A Cohort: Visit 1 | Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Negative | 22 Participants |
| Part B Cohort: Visit 1 | Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Negative | 5 Participants |
| Part B Cohort: Visit 1 | Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Positive | 19 Participants |
| Part B Cohort: Visit 2 | Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Positive | 16 Participants |
| Part B Cohort: Visit 2 | Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Negative | 7 Participants |
| Part B Cohort: Visit 3 | Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Positive | 15 Participants |
| Part B Cohort: Visit 3 | Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B | Negative | 5 Participants |
Primary
Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B
The quantitative UDS measures both buprenorphine and its glucuronide, or both norbuprenorphine and its glucuronide, with an LLOQ of 2 ng/mL. It is typically used by physicians for the confirmation of a positive result on the qualitative UDS. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is Not Available Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Time frame: Days 1, 30, 60
Population: Full analysis set includes participants who have at least one measure of buprenorphine or norbuprenorphine concentration in plasma or in urine in Part A. Four participants who tested positive for naloxone in urine were excluded from summary results. One participant was terminated from the study prior to Part B, Visit 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 32 Participants |
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 0 Participants |
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 31 Participants |
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 17 Participants |
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 1 Participants |
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 29 Participants |
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 19 Participants |
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 18 Participants |
| Part A Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 0 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 23 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 1 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 2 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 24 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 0 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 21 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 1 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 0 Participants |
| Part B Cohort: Visit 1 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 0 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 0 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 0 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 20 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 0 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 19 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 4 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 3 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 4 Participants |
| Part B Cohort: Visit 2 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 19 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 3 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 0 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 17 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 3 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 0 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 2 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 18 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 17 Participants |
| Part B Cohort: Visit 3 | Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 0 Participants |
Primary
Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B
The urine free drug test only measures the free buprenorphine and free norbuprenorphine (without their glucuronides) with an LLOQ of 0.02 ng/mL. Data are reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). For Bup+Nor (abbreviation for Buprenorphine + Norbuprenorphine), the result is negative if results for both are negative, the result is positive if either result is positive. If both are missing/not available, or one is negative and the other is missing/not evaluable, the result is Not Available Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior during previous phase III studies.
Time frame: Days 1, 30, 60
Population: Full analysis set includes participants who have at least one measure of buprenorphine or norbuprenorphine concentration in plasma or in urine in Part A. Four participants who tested positive for naloxone in urine were excluded from summary results. One participant was terminated from the study prior to Part B, Visit 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 46 Participants |
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 0 Participants |
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 3 Participants |
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 3 Participants |
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 46 Participants |
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 0 Participants |
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 0 Participants |
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 30 Participants |
| Part A Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 19 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 0 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 5 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 0 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 24 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 24 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 0 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 19 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 0 Participants |
| Part B Cohort: Visit 1 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 0 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 1 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 1 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 1 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 21 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 5 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 17 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 1 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 21 Participants |
| Part B Cohort: Visit 2 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 1 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Not Available | 0 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Positive | 20 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine - Negative | 0 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Norbuprenorphine- Not Available | 0 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Positive | 20 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Bup + Nor - Negative | 0 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Negative | 3 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Not Available | 0 Participants |
| Part B Cohort: Visit 3 | Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B | Buprenorphine - Positive | 17 Participants |